510(k) · Cleared
ClearedSensititre 18-24HR Susceptibility Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trek Diagnostic Systems, Inc. · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Feb 17, 2010 after a 63-day review. The FDA summary names no predicate by number.
- Decided
- Feb 17, 2010
- Review
- 63 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWY device
- #1 K260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)score 12.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JWY devicesJWY Manual Antimicrobial Susceptibility Test Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JWY
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWY
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWY
31in 2022
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · JWY
1in 2024
MAUDE reports naming product code JWY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 6 | 85 | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 4 | 73 | 0 | 0 |
| 2011 | 4 | 125 | 3 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 6 | 106 | 5 | 4 |
| 2015 | 9 | 90 | 6 (4) | 11 |
| 2016 | 4 | 88 | 0 | 20 |
| 2017 | 14 | 61 | 2 | 9 |
| 2018 | 12 | 51 | 0 | 13 |
| 2019 | 18 | 60 | 0 | 10 |
| 2020 | 5 | 66 | 0 | 20 |
| 2021 | 5 | 266 | 0 | 41 |
| 2022 | 0 | — | 31 (9) | 11 |
| 2023 | 7 | 85 | 0 | 9 |
| 2024 | 6 | 90 | 0 | 1 |
| 2025 | 14 | 106 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. The Sensititre 18 -24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates. This 510(k) is for the addition of Telavancin in the dilution range of 0.001-2 μg/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus…
Read the full statement (156 words)
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.
The Sensititre 18 -24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates.
This 510(k) is for the addition of Telavancin in the dilution range of 0.001-2 μg/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. and the Sensititre 18-24 hour MIC panel in the dilution range of 0.03-16 μg/ml for testing Gram positive clinical isolates.
The approved primary "Indications for Use" and clinical significance of positive isolates. Telavancin is for:
* Facultative Gram-Positive Microorganisms:
Staphylococcus aureus (including methicillin-resistant isolates)
Streptococcus pyogenes
Enterococcus faecalis
Streptococcus agalactiae
Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
In vitro data, without clinical correlation is provided for:
* Facultative Gram-Positive Microorganisms:
Enterococcus faecium (vancomycin-susceptible isolates only)
Staphylococcus haemolyticus
Streptococcus dysgalactiae subsp. equisimilis
Staphylococcus epidermidis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093865: Sensititre 18-24HR Susceptibility Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093865
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026